Renaissance Lakewood, LLC
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Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Renaissance Lakewood, LLC is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Neurology
Quick Facts
HQ:United States
Founded:2003
Employees:2,180
Capabilities & Services
Core Capabilities
- Cytotoxic / ADC Handling
- High-Potency API
- Sterile Fill/Finish
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Topical / Transdermal
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Global
Manufacturing Facilities
1 site worldwide
Renaissance Lakewood LLC
1200 Paco Way, Lakewood, New Jersey, 08701
Site Capabilities
4 capabilitiesANALYSIS
LABEL
MANUFACTURE
PACK
International Regulatory
EU GMP Certificates
3
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval 1Y6TCJ
Health Canada · #APR-0DJFJPC6 · 2018-03-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-NZANLQIJ
Issued: 2020-10-03
Expires: 2025-02-26
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-PUVAV7NN
Issued: 2020-04-05
Expires: 2025-06-15
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Key facts about Renaissance Lakewood, LLC
- Renaissance Lakewood, LLC is headquartered in the United States.
- Renaissance Lakewood, LLC was founded in 2003.
- Renaissance Lakewood, LLC has 2,180 employees.
- Renaissance Lakewood, LLC has one manufacturing site listed on CDMO Hub, in Lakewood, United States.
- Renaissance Lakewood, LLC's capabilities include Cytotoxic / ADC Handling, High-Potency API and Sterile Fill/Finish.
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